Head and neck squamous cell carcinoma
Conditions
Interventions
Group 1 :
Sponsors
Affiliated Tumor Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent with good compliance and follow-up; 2. Age 18-70 years, male or female; 3. Patients with locally advanced head and neck squamous cell carcinoma (III-IVb) confirmed by pathology, including oral, oropharyngeal, hypopharyngeal and laryngeal cancers; 4. The primary lesion was determined by the investigator to be suitable for surgical treatment or potentially operable without surgery or radiotherapy; 5. Recurrence after operation, and the researchers determined that reoperation was necessary or potentially operable; 6. Have at least one measurable lesion (RECIST1.1); 7. ECOG score: 0-1; the expected survival is greater than 6 months; 8. Never received systemic antitumor therapy; 9. The standard of routine blood examination shall meet (no blood transfusion or blood products within 14 days, no correction by G-CSF and other hematopoietic stimulating factors): (1) HB >= 90 g/L; (2) ANC >= 1.5 x 10^9/L; (3) PLT >= 80 x 10^9/L; 10. Biochemical examination should meet the following criteria: (1) TBIL 60 ml/min (Cockcroft-Gault formula); 11. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= the low limit of normal value (50%); 12. Women of childbearing age who were not sterilized underwent a pregnancy test (serum or urine) within 7 days prior to study entry and the results were negative, and were willing to use an appropriate method of contraception during the trial and for 8 weeks after the last dose of the test drug. For men, consent was required to use an appropriate method of contraception or to have been surgically sterilized during the trial period and for 8 weeks after the last administration of the trial drug.
Exclusion criteria
Exclusion criteria: 1. Received anti-angiogenic drugs (such as Sunitinib, sorafenib, regofenib, bevacizumab, imatinib, apatinib, etc.); 2. Patients with deep ulcers; patients with necrotic lesions or at risk of bleeding from tumors adjacent to important blood vessels as assessed by the investigator; 3. Bleeding symptoms of significant clinical significance or definite bleeding tendency occurred within the first three months of enrollment; 4. The patient is participating in another clinical study or less than 4 weeks after the end of the previous clinical study; 5. Present or present with other active malignancies within 5 years; patients who have had potentially curable therapy and have not had disease recurrence within 5 years after the start of therapy are excluded; 6. Patients who have received external radiation therapy within the last 3 months or received systemic anti-tumor therapy, including cytotoxic therapy and signal transduction inhibitors (or had used mitomycin C within 6 weeks before receiving the test drug therapy), should not use traditional Chinese medicine anti-tumor therapy at the same time; 7. Uncontrolled hypertension (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg, despite optimal medical treatment); 8. Adverse reactions caused by any previous treatment (except hair loss) did not recover to NCI-CTCAE 5.0 1.5 or PT > ULN + 4 seconds or APTT > 1.5 ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy. Note: Under the premise of INR = ++, or confirmed 24 hours of urine protein >= 1.0 g; 11. Received major surgical operations 28 days before enrollment; a wound or fracture that has not healed for a long time; 12. Patients with grade 3 or above pleural effusion or pneumothorax according to the NCI-CTCAE 5.0 grading standard; 13. Severe acute or chronic infections requiring systemic treatment; 14. Severe cardiovascular disease: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval >= 450 ms for men and 470 ms for women); according to NYHA criteria, patients with grade III-IV cardiac insufficiency or left ventricular ejection fraction (LVEF) = CTCAE 2, except for trauma; 16. Poor diabetes control (fasting blood glucose > 10 mmol/mL); 17. Having factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhoea and intestinal obstruction; 18. Clinically significant bleeding symptoms or definite bleeding tendency, such as respiratory tract bleeding, digestive tract bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, or vasculitis within 3 months before enrollment; patients whose tumor is radiographically shown to have invaded important vascular peripherals or whose tumor is judged to be highly likely to invade important vascular peripherals and cause fatal haemorrhage during subsequent studies; 19. Arteriovenous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage and cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preoperative objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Preoperative disease control rate;R0 resection rate;1 year local recurrence rate;1 year remote metastasis rate;security; | — |
Countries
China
Contacts
Public ContactXu Jian
Affiliated Tumor Hospital of Guangxi Medical University
Outcome results
None listed